MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER GUIDEWIRE; WIRE, GUIDE, CATHETER

Catalog Number	9-GW-002
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, an amplatzer guidewire was chosen for the procedure.During device insertion into the patient, it was indicated that the physician experienced great roughness in the material.Small wrinkles (gripping) on the guidewire were observed.The device was used with no further complication.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of material deformation (roughness/small wrinkle) of the guidewire was reported.A returned device inspection, to rule out any device-related causes, could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6)2024, an amplatzer guidewire was chosen for the procedure.During device preparation, prior to introduction into the patient, it was indicated that the physician experienced great roughness in the material.Small wrinkles (gripping) on the guidewire were observed.The device was used with no further complication.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
H6 type of investigation code 4114 was removed.An event of material deformation (wrinkle) of the guidewire was reported and cannot be confirmed.Additionally, it was observed that the coating of the guidewire was not smooth (damaged).The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2024, an amplatzer guidewire was chosen for the procedure.During device preparation, prior to introduction into the patient, it was indicated that the physician experienced great roughness in the material.Small wrinkles (gripping) on the guidewire were observed.The device was used with no further complication.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.

• Brand Name: AMPLATZER GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18671633
• Report Number: 2135147-2024-00589
• Device Sequence Number: 12544768
• Product Code: DQX
• UDI-Device Identifier: 00811806010724
• UDI-Public: (01)00811806010724(17)280531(10)9943922
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K053187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9-GW-002
• Device Lot Number: 9943922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 03/29/2024; 09/19/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 04/03/2024; 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 14 MO
• Patient Sex: Male